Open Orphan executive chair Cathal Friel. Image: Open Orphan
Hvivo will enrol healthy volunteers to test the efficacy of a biotech company’s oral vaccine candidate for Covid-19.
A subsidiary of Dublin-based pharma services company Open Orphan said it is developing the world’s first human challenge model involving the Omicron variant of Covid-19.
Open Orphan’s Hvivo subsidiary plans to manufacture a new challenge agent based on the Omicron strain of SARS-CoV-2. This will be used to test the efficacy of an oral vaccine candidate from biotech company Vaxart.
Hvivo aims to complete the manufacturing of the agent by the fourth quarter of this year. It then expects to conduct Omicron human challenge studies in 2023, after it receives regulatory approval and completes a characterisation study of the manufactured strain.
“Hvivo’s fight against the pandemic continues with the development of this new challenge agent,” Open Orphan CEO Yamin Khan said. “The benefits to Vaxart are immense, and we have already been contacted by a number of biopharma companies looking to test the efficacy of their products using this challenge virus.”
Human challenge trials involve the deliberate exposure of human volunteers to infectious agents in a controlled setting. Hvivo specialises in these challenge trials to assess the efficacy of vaccines or treatments for clients.
Last year, Hvivo signed an £8.1m contract to test an inhaled antiviral product as part of its asthma human challenge study. The company was also involved in a Covid-19 human challenge study, which was published in March in the Nature Medicine journal.
Khan believes the results of that trial gave customers the confidence to move forward with an Omicron challenge model, which is “less severe yet more infective”.
The characterisation study will give a dose of the Omicron challenge agent to a group of healthy volunteers. Hvivo said these men and women will have been previously vaccinated against or infected with Covid-19, with no known risk factors for severe symptoms.
Vaxart chief medical officer Dr James Cummings said a human challenge study involving the company’s oral vaccine against the Omicron variant is the “most rapid and direct way” to test its effectiveness.
“The results of this study will inform the next steps in the development of our Covid-19 vaccine candidate, which has the potential to transform personal and public health approaches to controlling the global pandemic,” Cummings added.
Open Orphan is a specialist contract research organisation that tests vaccines and antivirals through human challenge clinical trials.
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